Emano Metrics, Inc. recalls Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a…

Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.

On 06/10/2026, a "Medical Device Correction" Letter was emailed to customers informing them that it would found that Emano Flow software versions v2.2.0-v2.3.4 processed audio at a sample rate that did not match the sample rate expected by the flow prediction algorithms (model version v2.0.0), affecting results generated between 03/22/2026 to 05/29/2026. Customer were also informed that, the correction (updated software) was deployed on May 29, 2026. An updated customer notice was emailed on 06/23/2026. Instructions provided to Customer included: 1. Review the corrected results for patients with Emano Flow data from the affected period, prioritizing cases where the data informed a clinical decision. 2. If customers have previously downloaded patient reports generated between 03/22/2026 and 05/29/2026, replace them with the corrected versions available in the Emano Flow clinic portal. A spreadsheet with secure links to all corrected reports is attached. 3. Please reply to this email to confirm receipt of this notice.

• FDA enforcement recordOfficial FDA database entry for Z-2777-2026
• FDA device classification · EXYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Emano Metrics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.